Instruments for delivering transfascial sutures, transfascial suture assemblies, and methods of transfascial suturing

ABSTRACT

An instrument for delivering a suture transfascially may include a handle, a shaft extending from the handle, and a pair of needles that are moveable to an extended position beyond the end of the shaft. One or more sutures are carried by the instrument and may be delivered transfascially. A transfascial suture assembly includes a suture having a first segment, a second segment, and an intermediate segment therebetween. A force distributing member is locatable at the intermediate segment. Suture retainers may be provided at the end of each suture segment, and may have a connection that is moveable relative to the portion of the suture segment connected therewith. A method of delivering transfascial sutures includes inserting a twin-needle instrument loaded with one or more sutures into an abdominal cavity and deploying, from within the abdominal cavity, the suture carrying needles through a soft tissue repair patch and then through at least part of the abdominal wall.

FIELD

The invention relates to instruments for delivering transfascialsutures, to transfascial suture assemblies, and to methods oftransfascial suturing.

BACKGROUND

Ventral hernia repair routinely involves placement of a soft tissuerepair prosthetic, typically in the form of a patch, across an abdominalwall defect. In a laparoscopic procedure, or other minimally invasiveapproach, the patch is reduced in size and delivered through a narrowcannula or incision into the abdominal cavity where it then is returnedto an expanded shape and deployed against the abdominal wall. Suturesmay be applied through a partial, if not full, thickness of theabdominal wall (i.e., transfascial suturing). Additionally, oralternatively, tacks, screws, coils or other fasteners may be placedthrough the patch into just the innermost layers of the abdominal wall,such as the peritoneum and posterior fascia.

A conventional approach for transfascial suture delivery, as shown inFIG. 1, proceeds from outside of the patient. Sutures are pre-tied atspaced locations 100 about a patch 102 periphery, with pairs of suturetails 104 extending from each knot. It is these tails that will bridgethe fascia and be secured together to form the transfascial suturefixation. The patch, pre-loaded with sutures, is collapsed and deliveredinto the abdominal cavity.

A suture passer instrument 106 is inserted, from outside of the patient,through the abdominal wall 108 and into the abdominal cavity in theapproximate location of a particular suture tail pair. The suture passerincludes a jaw or other grasper type arrangement which is operatedwithin the cavity to capture one of the suture tails. The suture passeris retracted back through and out of the abdominal wall, drawing thesuture tail exteriorly of the abdominal cavity. A hemostat or otherclamp is applied to the exposed suture tail, preventing slippage of thesuture tail back into the abdominal cavity. The suture passer isinserted again through the abdominal wall, creating a new punctureadjacent the first puncture, and operated to grab the remaining suturetail. The suture passer is pulled outwardly from the abdominal cavity,retrieving the second suture tail which also can be clamped against theanterior fascia. This standard transfascial suturing technique,approached from outside of the abdominal cavity, is repeated until allof the suture tail pairs have been transfascially deployed and tiedtogether, typically at small skin incisions such that the tied knots arein the subcutaneous space.

SUMMARY

One aspect of the invention is a method of delivering a transfascialsuture including providing a soft tissue repair prosthetic in anabdominal cavity of a patient and then passing, from within theabdominal cavity, a suture first through the soft tissue repairprosthetic and then through at least a part of the abdominal wall.

Another aspect of the invention is a method of delivering a transfascialsuture with a suturing instrument that has been inserted into anabdominal cavity. The suturing instrument has a pair of needles and isloaded with at least one suture defined by a pair of suture segments,with each needle being associated with one of the pair of suturesegments. Each of the needles is advanced from the suturing instrumentthrough at least a part of the abdominal wall.

Another aspect of the invention is a method of delivering a transfascialsuture including the acts of providing a suture that is defined by apair of segments, each segment having a tail end and a section proximalthe tail end, and passing each proximal section of a suture segment,before passing each tail end, through at least a portion of theabdominal wall.

Another aspect of the invention is a method of delivering a transfascialsuture including providing a soft tissue repair prosthetic, and a suturedefined by a pair of segments, each segment including a suture retainer,in an abdominal cavity. Passing, from within the abdominal cavity, eachof the suture retainers through the soft tissue repair prosthetic and atleast part of the abdominal wall, with each of the suture segmentsfollowing a respective suture retainer through the soft tissue repairprosthetic and abdominal wall. The pair of suture segments that havepassed through the abdominal wall are then secured together, such as bytying.

Another aspect of the invention is a method of delivering a transfascialsuture including the acts of creating an opening in a soft tissue repairprosthetic located in an abdominal cavity by passing a suture throughthe soft tissue repair prosthetic, and then at least partially coveringthe opening with a force distributing member carried by the suture.

Another aspect of the invention is a method of inserting an instrumentinto an abdominal cavity. The instrument includes at least one tissuepiercing member having a sharp end adapted to pierce abdominal walltissue, and the instrument has a non-piercing mode with the sharp end ofthe tissue piercing member being shielded against contact with abdominalwall tissue and a piercing mode with the sharp end of the tissuepiercing member being available for contact with abdominal wall tissue.The method includes inserting the instrument in the non-piercing modeinto the abdominal cavity with the sharp end of the at least one tissuepiercing member being shielded from contact with the abdominal walltissue, and positioning the instrument in the non-piercing mode adjacentthe abdominal wall. After positioning the instrument, the instrument isactuated to the piercing mode, and the at least one tissue piercingmember is advanced through at least a part of the abdominal wall withthe instrument in the piercing mode.

Another aspect of the invention is an instrument for delivering atransfascial suture including a handle and an elongated shaft extendingfrom the handle, the shaft including a distal end. The instrument alsoincludes a first needle and a second needle, the first and secondneedles being moveable to an extended position beyond the distal end ofthe shaft. Each needle has a sharp end adapted to pierce a soft tissuerepair prosthetic and abdominal wall tissue. A suture is carried by theinstrument, the suture defined by a first segment and a second segment,and including a suture force distributing member between the first andsecond segments. The suture is arranged in the instrument so that thesuture segments are carried by the needles as the needles move to theextended position.

Another aspect of the invention is an instrument for delivering atransfascial suture including a handle and an elongated shaft extendingfrom the handle, the shaft including a distal end. The instrument alsoincludes a first needle and a second needle, the first and secondneedles being moveable to an extended position beyond the distal end ofthe shaft. Each needle has a sharp end adapted to pierce a soft tissuerepair prosthetic and abdominal wall tissue. Each needle also includes asuture receiving channel. A suture is carried by the instrument. Thesuture is defined by a first segment and a second segment, the firstsegment is located in the first suture receiving channel and the secondsegment is located in the second suture receiving channel.

Another aspect of the invention is an instrument for delivering atransfascial suture including a handle and an elongated shaft extendingfrom the handle, the shaft including a distal end. The instrumentincludes a first needle and a second needle, the first and secondneedles being moveable to an extended position beyond the distal end ofthe shaft. Each needle has a sharp end adapted to pierce a soft tissuerepair prosthetic and abdominal wall tissue. The instrument includes aplurality of sutures indexed according to a delivery sequence, and isconfigured to register a next indexed suture in the delivery sequencewith the first and second needles.

Another aspect of the invention is an instrument for delivering atransfascial suture including a handle and an elongated shaft extendingfrom the handle, the shaft including a distal end. The instrumentincludes a first drive member and a second drive member, the first andsecond drive members being moveable along respective drive paths to anextended position beyond the distal end of the shaft. The instrumentcarries a suture, the suture defined by a first segment and a secondsegment. A first suture retainer is connected to the first segment andis located in a first drive path, and a second suture retainer isconnected to the second segment and is located in a second drive path,the first and second suture retainers being carried by the instrument.

Another aspect of the invention is a tip for a transfascial suturedelivery instrument including a tip body having a first needle pathwayand a second needle pathway. Each of the first and second needlepathways being registrable with a respective first needle channel and asecond needle channel in a transfascial suture delivery instrument. Theinstrument includes at least one suture defined by a first segment and asecond segment, the first and second suture segments, or a retainerassociated with each of the first and second suture segments, beinglocated along the first needle pathway and the second needle pathway,respectively. The tip body is adapted to removably fit to thetransfascial suture delivery instrument with the first and second needlepathways registered with the first and second needle channels.

Another aspect of the invention is a tip for an instrument fordelivering a transfascial suture including a tip body having a firstneedle pathway and a second needle pathway. Each of the first and secondneedle pathways have a portion adapted to register with a respectivefirst needle channel and a second needle channel in a transfascialsuture delivery instrument. The tip body includes at least one suturedefined by a first segment and a second segment. An elongated sutureenclosure extends proximally of the first and second pathways, the firstand second segments being located within the elongated suture enclosure.The tip body is adapted to fit to the transfascial suture deliveryinstrument with the first and second needle pathways registered with thefirst and second needle channels.

Another aspect of the invention is a suture assembly including a suturehaving a first segment, a second segment, and an intermediate sectionbetween the first segment and the second segment. A first sutureretainer is connected to the first segment, and a second suture retaineris connected to the second segment. A suture force distributing memberis positioned about the intermediate section.

Another aspect of the invention is a suture assembly including a sutureand a suture retainer. The suture retainer includes a connector toconnect with the suture. The position of the connector being selectivelyadjustable along the length of the suture. The suture retainer includesan axial bore therethrough for receiving a needle.

Another aspect of the invention is an instrument for delivering atransfascial suture including a handle and an elongated shaft extendingfrom the handle, the elongated shaft including a distal end. A needleextends through the elongated shaft and is advanceable beyond the distalend, the needle including a sharp tip and a drive feature. A pluralityof suture retainers are stacked in an end-to-end orientation on theneedle, each pair of suture retainers connected to a single suture. Astop is provided at the distal end, the stop adapted to be overcome byneedle induced movement of the distal-most suture retainer. The drivefeature has a firing profile to drive the distal-most suture retainerthrough the stop and out of the distal end when the needle is moved inthe distal direction, and a reloading profile allowing the drive featureto move past the next distal-most suture retainer as the needle is movedin the proximal direction.

A still further aspect of the invention is an instrument for deliveringa transfascial suture including a handle, an elongated shaft extendingfrom the handle, the shaft including a distal end. A pair of needlesextend through the shaft and are advanceable beyond the distal end. Theinstrument includes a pick-up area and a loading zone in the distal end.A suture including a force distribution member is located in the pick-uparea, and one or more sutures each including a force distribution memberare located in the loading zone. A translating feature moves a sutureand force distribution member from the loading zone to the pick-up area.

BRIEF DESCRIPTION OF DRAWINGS

The foregoing and other objects and advantages of the invention will beappreciated more fully from the following drawings, wherein likereference characters designate like features, in which:

FIG. 1 is an illustration of a conventional transfascial suturedelivery;

FIGS. 2-5D are illustrations of an instrument for transfascial deliveryof a suture;

FIGS. 6-8 are illustrations an instrument for transfascial delivery of aplurality of sutures;

FIGS. 9-13 are illustrations of an instrument for transfascial deliveryof a suture including a reusable unit and a disposable tip;

FIGS. 14-15 are illustrations of a suture retainer with a tissuepiercing tip;

FIGS. 16A-21B are illustrations of various suture retainers;

FIGS. 22-25C are illustrations of an instrument for transfascialdelivery of a plurality of sutures;

FIGS. 26A-27 are illustrations of an instrument for transfascialdelivery of a plurality of sutures;

FIGS. 28A-28B are partial sectional illustrations of a drive mechanismfor an instrument for transfascial delivery of a suture;

FIGS. 29-32C are illustrations of an instrument for transfascialdelivery of a plurality of sutures;

FIGS. 33-33C are illustrations of an instrument for transfascialdelivery of a suture assembly including implantable retainers;

FIGS. 34-34D are illustrations of an instrument for transfascialdelivery of a suture assembly including a subcutaneous anchor; and

FIG. 35 is an illustration of a ventral repair patch and an inflatabledeployment assist device.

DETAILED DESCRIPTION

Various aspects of the invention are described below and/or shown in thedrawings. These aspects of the invention may be used alone and/or in anysuitable combination with each other. Aspects of the invention are notlimited in any way by the illustrative embodiments shown and describedherein.

Embodiments of the invention are described in connection withinstruments for transfascial delivery of one or more sutures,arrangements of transfascial suture assemblies, and methods ofdelivering a transfascial suture. These instruments, suture assemblies,and methodologies are particularly configured for transfascial deliveryof sutures from within the abdominal cavity to the outside of thepatient, rather than in the traditional manner of pulling sutures acrossthe fascia in an approach from outside of the patient. Such instruments,suture assemblies, and techniques may be applied independently or inconjunction with other approaches, such as those involving mechanicalfastener-type fixation. Although disclosed in connection with a repairof a ventral hernia, the invention is not so limited and has otherapplications as should be apparent to one of skill in the art.

An instrument for transfascial delivery of a suture may include anactuating handle, an elongated shaft extending from the handle, one ormore sutures loaded in the instrument and a drive system for advancingthe suture out of the instrument. The shaft may be flexible, may beconfigured with a selectively articulating tip, may be selectivelyrotatable, and may be sized to fit through a narrow cannula, such as a 5mm cannula or even smaller—although the outer diameter of the shaft isnot necessarily a limitation of the invention.

The drive system may include one or a pair of needles or other driveelements, each with an end configured for piercing tissue and/or a softtissue repair prosthetic, such as a ventral hernia patch. A pair ofdrive needles may be arranged to move simultaneously or, instead, insequence, and may be driven by a single or a dual actuating arrangement(e.g., one trigger or two triggers).

The instrument may have a non-piercing mode with a sharp end of eachneedle or other tissue piercing member being shielded against contactwith abdominal wall tissue and a piercing mode with the sharp end of theneedle being available for contact with abdominal wall tissue. Theinstrument may be inserted in the non-piercing mode into the abdominalcavity. After positioning adjacent the abdominal wall, the instrumentmay be actuated to the piercing mode, and the needle may be advancedthrough at least a part of the abdominal wall.

The one or more sutures may be in carrying engagement with the needlesas-loaded, or may be positioned in a path of movement of the needles sothat the suture is picked up and advanced out of the instrument by themoving needles. The suture may be arranged so that a first suturesegment is associated with a first needle and a second suture segment isassociated with a second needle, with an intermediate suture segmentextending between the two. So arranged, deployment of the pair ofneedles will deliver both suture segments through a ventral hernia patchand then through fascial tissue, with the intermediate segment remainingin the abdominal cavity internal of the ventral repair patch. Theportions of the first and second suture segments delivered through andbeyond the patch and fascial tissue, referred to as suture tails orsuture segment tails, may then be joined, such as by tying, and prior tojoining may be pulled to draw the intermediate segment against theventral repair patch.

A suture force distributing member may be provided along theintermediate segment of the suture, so that the force distributingmember contacts the ventral repair patch when the suture tails are drawnaway from the abdominal cavity and/or secured together. The suture forcedistributing member may be fixed in position on the intermediate segmentor may ‘float’ along the intermediate segment.

Where a plurality of sutures are loaded in an instrument, an indexingsystem may be provided to deliver the sutures according to apredetermined sequence, and such indexing system may be axially based,rotationally based, or otherwise. The instrument may be arranged toprovide for tangle-free storage of a plurality of sutures. Further, theinstrument may be configured as a reusable device, a disposable device,or a hybrid including a reusable aspect and a disposable aspect. Such ahybrid device might include, for example, a reusable handle and shaftand a disposable tip and suture assembly that is mountable to the shaft.A safety mechanism may be provided to prevent firing of the needle whenno sutures are present, or are not properly loaded, in the instrument.The instrument and suture assemblies preferably will be sterilized priorto transfascial suturing.

One embodiment of a transfascial suture delivery instrument 200 isillustrated in FIGS. 2-5D (handle is not shown) and is arranged todeliver a suture 202 defined by a first segment 204, a second segment206 and an intermediate segment 208. The first segment may be positionedwithin the channel 210 of a needle 212 or otherwise contained within theneedle. The second segment may be similarly positioned with respect tothe second needle 214. Locating the first and second suture segmentswithin the first and second needles may allow for a reduced instrumentprofile. However, the suture segments could be positioned externally ofthe needles (anywhere about the circumference of the needle includingbetween the needles), or partially internal of the needles and partiallyexternal of the needles. For example, and without limitation, the suturesegments could extend across each, respective, needle tip and then runalong opposite sides of the needle bodies. Further, the suture segmentsmay be extended partially or fully lengthwise, that is essentially orpartially linearly, or may be partially or fully reduced in length suchas being in the form of loops or coils. In any of such arrangements, itis preferable to load and deliver the suture segments in a fashion thatminimizes tangling. The internal or external surface of the needles maybe coated or otherwise finished to facilitate delivery of the suturesegments without damaging the suture.

The tips of each of the needles may be pointed to facilitate piercing ofa ventral repair patch P and/or abdominal wall tissue W. The needles mayinclude a notch 216, 218 or other feature to assist in picking up and/orpaying out the suture segments as the needles are deployed. Theas-loaded suture may be in an inverted U-shaped configuration as shown,with the tail ends of the suture segments being closer to the proximalend of the shaft 219. Consequently, when the needles are deployed from anon-piercing mode, as shown in FIG. 5A, to a piercing mode, as shown inFIG. 5B, the portions of the suture segments closer to the intermediatesegment are first delivered from the instrument with the portions of thesuture segments closer to the tail ends, or the tail ends themselveswhere the entire suture segments are released from the instrument, beingdelivered later. After deployment, respective suture tail pairs may beknotted, excess suture length trimmed, and the skin over the suture knotclosed by stitching, adhesive strip or otherwise, as shown in FIGS.5C-5D.

A force distributing member 220 may be provided along the intermediatesegment of the suture, and may be located between the needles in theas-loaded arrangement as shown or may be moved into position between theneedles at a point during needle deployment. The force distributingmember may be fixed in position to the suture or may be freely moveablealong a length of the suture (i.e., floating). In a fixed embodiment,the force distributing member may be joined to the intermediate segmentthrough mechanical arrangements, such as by crimping the forcedistributing member to the segment or by one or more clamps or wedgesprovided in the force distributing member that may be engaged to thesegment. Alternatively, and again without limitation, the suture may betied to the force distributing member to fix the position at theintermediate segment. Additionally, the force distributing member may bejoined by thermal or chemical bonding with the suture, by heat shrinkingthe force distributing member to the suture, or by an adhesive appliedbetween the two components. Further, the force distributing member maybe integrally formed with the suture, such as by hardening or reshapinga portion of the suture. The force distributing member is not limited tothe tubular shape shown, as should be apparent to one of skill in theart, and may have other configurations such as a substantiallyplate-like or planar arrangement (including, without limitation, flat,slightly convex, slightly concave, and hybrids of the foregoing) withsuch substantially planar embodiments including any design suitable forspreading forces applied along the suture. An alternative arrangement isan hourglass or bow-tie configuration (shown as 220 a in FIG. 4) withopenings therethrough, or along contoured edges, for passage of thesuture segments. Other three-dimensional and substantially planarshapes, as well as compound shapes including three-dimensional andplanar aspects, are contemplated as one of skill in the art willappreciate. Further, one or more surfaces of the force distributingmember may be adapted for contact or engagement with the soft tissuerepair prosthetic. For example, a tubular shaped force distributingmember may include one or more specially shaped surfaces, or facets,about its circumference, which may be planar, convex, concave, or otherarrangement suitable to promote contact or engagement between the forcedistributing member and the soft tissue repair prosthetic. The forcedistributing member may be formed of a permanent material (e.g.,polypropylene, polycarbonate, nylon, polyester, stainless steel,titanium), an absorbable material (e.g., polyglycolic acid (PGA),polylactic acid (PLA), polydioxanone (PDO), and blends of any of theforegoing), or a hybrid of a permanent material and an absorbablematerial.

A transfascial suture delivery instrument 300 arranged to deliver amultiple of pre-loaded sutures 302 a-d is illustrated in FIGS. 6-8. Thesutures may be in a form similar to the suture described in connectionwith FIGS. 2-4, characterized by a first segment, a second segment, andan intermediate segment to which a force distributing member may beprovided. The sutures may be indexed in an intended delivery sequence.In the axial index shown, the distal-most suture 302 a will be deliveredfirst, the next distal-most suture 302 b will be delivered second, withthe indexing continuing in this fashion along the length of the stack.

An inner cannula 304 may be provided with pairs of slots 306 a-d ofvarying length corresponding to respective positions in the index order.For example, the distal-most suture may be located in a pair of slotswhich is located closest to the distal tip of the instrument and,consequently, the pair of slots associated with the distal-most suturehave a length shorter than the pair of slots for the next distal-mostsuture.

The axial indexing arrangement may be reversed so that the distal-mostsuture is the last suture delivered by the instrument and, further,other delivery sequences for an axial stacking arrangement may beemployed as should be apparent to one of skill in the art. The indexingsequence also, or alternatively, may be characterized by rotationalpositioning about the circumference of the inner cannula. For example,the first suture may be located at a reference location, and then thesecond suture in the sequence located at a predetermined angularadjustment from the reference location (i.e., first suture), and thenthe third suture at a further angular adjustment from the second suture.The angular adjustments may be the same or varying as between differentsuture positions in the indexing sequence. For example, and withoutlimitation, the angular adjustment between different suture indexpositions (e.g., pairs of slots) may be 30 degrees, allowing 6 differentsutures to be indexed for a single circumferential indexing arrangement.As a further example, also non-limiting, a rotational offset of 45degrees would permit circumferential indexing of 4 sutures, as shown inFIGS. 6-8.

As shown, the sutures are indexed axially and rotationally, with thefirst and second segments of each suture hanging over and draped alongthe outer surface of the indexing cannula, with the intermediatesegment, with or without a force distributing member, extending acrossand internally of the indexing cannula. The indexing cannula may includeouter partitions, ribs, or other features to maintain the separatenessof the suture segments and avoid tangling therebetween. As describedabove and shown, the suture segments may be fully extended in alengthwise direction or may be partially or substantially completelyreduced in length, for example by being looped into coils. If desired,the indexing cannula may include an outer wall that shrouds the suturesegments, and such an arrangement may facilitate assembly and insertionof a suture loaded indexing cannula into the instrument. One or more ofadjacent, axially stacked, intermediate segments may be spaced from eachother or, alternatively, may be in contact.

A pair of needles 308 are advanceable to deliver each suture from theinstrument in the desired indexing sequence. The needles may be locatedwithin the indexing cannula, or otherwise arranged to pick-up or carry asuture from within the indexing cannula, as shown. Alternatively, theneedles may be located externally of the indexing cannula or otherwisearranged to pick-up or carry a suture externally of the indexingcannula.

The needles may be adapted for piercing the soft tissue repairprosthetic and fascial tissue, and may include one or more featuresadapted to pick-up and pay out the suture segments as the needles aredeployed, for example, the notched 310 arrangement shown. The needlesmay be solid or hollow, as the structure of the needles is notnecessarily a limitation of the invention as should be apparent to oneof skill in the art.

The stroke of the needles may be coordinated with the indexing locationof the sutures. For example, in certain embodiments where the suturesare stacked axially, the needles must be retracted far enough to reachthe proximal-most suture in the index. The stroke length in theseparticular embodiments, then, must be designed to reach theproximal-most suture for each retraction of the needle. Alternatively,in other axial indexing embodiments, the stroke length may be dynamicand vary depending upon the sequence order of the suture beingdelivered.

The needles may be rotated a predetermined angular adjustmentcorresponding to the next suture position in the index, and suchrotational indexing may occur automatically in response to actuation ofthe instrument, such as at the end of the backstroke of the prior suturedelivery or at some other interval, or may occur manually, as should beapparent to one of skill in the art. Once rotated, the needles are resetto pick up the next suture in the sequence. Alternatively, the indexingcannula may be arranged to rotate, while the needles remain in the sameorientation, whether automatically in response to actuation of theinstrument, for example at the end of the backstroke of the prior suturedelivery, at some other interval, or manually.

An instrument 400 for delivering a transfascial suture is shown in FIGS.9-13 and includes a reusable unit 402 having a handle 404, an elongatedshaft 406 and a drive assembly included within and actuatable at thehandle, and a disposable unit 408 including a tip 410 and sutureassembly 412. The reusable unit includes a pair of drive elements 414,which may be in the form of needles, that extend along the elongatedshaft and are deployable and retractable in response to actuation of acontrol mechanism at the handle.

As shown, the path of the drive elements or needles may diverge,increasing the spacing between the needles beyond the instrument and theamount of tissue purchase thereby. Alternatively, the drive elementpaths may be parallel or converging. The drive elements may run on asurface of the shaft but, preferably, are located in one or a pair ofchannels 416 running through the shaft as illustrated.

The distal face of the shaft may include an exit opening of therespective channels through which the drive elements may extend whendeployed. The surface of the shaft may be contoured 420, as shown, tocooperate with an interface feature 422 in the disposable tip and alsomay be adapted to receive a suture support 424, both described furtherbelow. Although shown with a truncated elliptical cross-section, theshape of the shaft is not so limited as should be apparent to one ofskill in the art.

The disposable tip includes a body portion 426 with a distal extension428 and a proximal extension 430. The proximal extension is shaped tomount about the distal portion of the shaft and includes an interface422 for snap fitting into the complementary recess 420 in the shaft. Thelocation of these complementary interface features could be reversed andother arrangements for releasably engaging the disposable tip to theshaft are contemplated as should be apparent to one of skill in the art.

In one embodiment, a releaseable interface between the distal shaft faceand proximal face of the tip body may be provided, such as a male/femalearrangement 432, 434 shown, which assist in the releasable connectionbetween the two components and may be in lieu of the proximal extensionand shaft interface. The tip body includes a pair of drive channels 436with openings that are registrable, respectively, with the first andsecond exit openings in the distal face of the shaft. The distalextension includes a pair of drive paths 438 that continue from thedrive channels extending through the tip body. Wall structure may bebuilt up around, and/or between, the drive paths to guide and/or supportthe drive elements.

Extending proximally of the tip body is a support 424 for a pair ofsuture segments. The support may be tubular shaped and may be integralwith the proximal extension or a separate component that extends fromthe tip body along the extension, whether internal of the extension asshown, or external of the extension if desired. The suture support mayform a single channel or may be divided, fully or partially, orotherwise configured to maintain first and second suture segmentsseparate from each other. The support is arranged to mount to the shaft,such as by seating in a complementary recess 440 formed in the shaftsurface. As shown, the complementary recess may be in the form of anelongated concave depression, bounded by convex walls. Otherarrangements of a mount for the suture support are contemplated and thisparticular configuration is not necessarily a limitation of theinvention. The suture support communicates with an opening through thetip body which may include a mount 442 or support for a forcedistribution member 444, such as the washer-type device shown. Theopening may include a divider presenting a first segment opening and asecond segment opening.

A suture retainer 450 may be located in each of the drive paths, witheach retainer connected to one of the suture segments 452 extendingthrough the opening or openings in the tip body. The suture retainersare adapted to receive and be carried by the drive elements as they areadvanced from the shaft of the reusable unit, through the tip body andalong and beyond the distal extension of the tip. In one embodiment, thesuture retainers each include an axial through-bore for receiving aportion of a needle tip. The bore and/or needle may be configured soonly part of the needle will project through the retainer. For example,and without limitation, the needle may include a necked down narrow tipportion that is extendable through and beyond the retainer bore, and astepped up larger proximal portion that is engageable with the retainer,for example with an internal or external shoulder of the retainer.

As shown, the force distribution member may be arranged in floatingrelationship with the suture segments; that is, the force distributionmember need not be fixedly located at a singular position on the suture.After both suture segments are fully deployed out of the instrument,whether by advancement of the needles or by pulling of the suture tailsor tail segments that have been transfascially delivered, the forcedistributing member and intermediate segment will position against thesoft tissue repair patch. Prior to full deployment, the forcedistribution member may stay with the disposable tip or may be suspendedby the moving suture segments even though displaced from the instrument.

The suture retainers are carried by the needles from the instrumentthrough the soft tissue repair prosthetic and/or fascial tissue,presenting on the other side of the abdominal wall. Upon completion ofthe instrument stroke, the needles retract back through the fascia andabdominal wall patch, leaving a first suture segment running from afirst suture retainer located exterior of the abdominal cavity, to anintermediate segment and force distribution member internal of theabdominal cavity and positionable against the abdominal wall patch, andback to a second segment running from the force distribution memberthrough the abdominal wall patch and fascia to a second retainer locatedexterior of the fascia. The deployed retainers may be reoriented,automatically or manually, so that the retainers are unlikely to slipback through the needle puncture openings. The retainers hold the suturesegments in place pending tying, or other securing, of the suture tailstogether. The retainers may be left as deployed, pending delivery ofother sutures about the abdominal wall patch, or the surgeon may chooseto tie or otherwise connect the ends of each pair of suture tails priorto delivering the next suture. Prior to tying together or otherconnection of the suture tails, the suture segments may be pulled totake up any excess suture slack still remaining in the instrument or inthe abdominal cavity, preferably while holding the suture retainersagainst the patient. Where the soft tissue repair patch is not alreadypositioned flush against the abdominal wall, such retraction of thesuture segments may help hoist a portion of the patch into position.

Although just described with an axial-through bore for receiving aneedle, the suture retainer may have a different arrangement, as shownin FIGS. 14-15, where the suture retainer 500, itself, is formed with atip 502 that is sharp and otherwise adapted to pierce the abdominal wallprosthesis and/or abdominal wall. In this embodiment, then, the sutureretainer does not have to be configured to extend a needle therethrough,and may be solid or include only a partially extending axial-bore 504.The tip of the drive elements will be configured to appropriately engagewith and advance such alternatively designed suture retainers. Forexample, and without limitation, the suture retainer may include apartial axially extending bore, and the drive element may include acylindrical portion that is compatible and just slightly narrower thanthe bore so as to fit within and be removable from the bore withoutcatching. For a solid suture retainer, the proximal face may includefeatures such as notches or projections, or other arrangements, thatprovisionally engage with complementary features in the distal end ofthe drive element.

Various suture retainer arrangements are shown in FIGS. 16A-21B. Asuture retainer 600 may include a tapered distal end 602 to assist inadvancement through the soft tissue repair prosthetic P and the fascialtissue W. A proximal portion 604 may be wider than the distal end,making it more difficult for the suture retainer to pass back throughthe puncture formed through the fascia and abdominal wall prosthesis,and such enlargement may be symmetrical or asymmetrical. In certainembodiments, the proximal portion includes a side body 606 that extendsradially from the main retainer body. The side body may be tubularshaped, or at least present a curved outer wall, and have a distalportion 608 that tapers towards the retainer body. The side body mayserve as a connector between the retainer and the suture segment.

In the embodiment of FIGS. 16A-16B, the suture segment is fixed at theconnector such as by insert molding, adhesive or ultrasonic bondingsections of the connector about an end of the suture segment,mechanically clamping or otherwise mechanically securing the end of thesuture segment to the connector, or other approach as should be apparentto one of skill in the art. Alternatively, the connector may beconfigured to allow the suture segment to move therethrough, so that thelocation of the suture segment within the connector is selectivelyvariable. In such cases, an end of the suture segment may be knotted,formed in a bulbous shape, or otherwise configured so as not to passthrough the connector, preventing the suture segment from slipping out.Although described as a substantially tubular side body, otherconfigurations of a connector for a suture segment are contemplated asshould be apparent to one of skill in the art.

As illustrated in FIGS. 17A-21B, the connector may include an axial bore610 extending at least partially through the connector.

The axial bore may open 612 transversely through the connector sidewall,as shown in FIGS. 17A-17B, and include a wedge or other suture lockarrangement that is actuated by pulling the suture segment axiallythrough the connector and then over the connector and back in thedirection of the proximal end. Where there is tension on the suturesegment, the already delivered suture retainer may stand upright againstthe fascia.

A portion of the connector at a proximal end may include a side-cut 614,as shown in FIGS. 18A-18B, or other arrangement that allows the sutureretainer to tip over and lay transversely to the direction of the suturesegment (e.g., flat against the fascia) that has escaped through theside-cut. Here, again, a wedge or other suture locking feature may beincorporated in a transverse opening in the connector sidewall.

In a further embodiment illustrated in FIGS. 19A-19B, a tipping arm 616may extend from the connector or other aspect of the retainer, aboutwhich the suture segment may be wrapped to encourage tipping of theretainer.

In an arrangement shown in FIGS. 20A-20B, a connector includes an axialbore 620, a first opening 624 through the connector sidewall and asecond opening 622 in the connector sidewall, in the form of a slot,spaced from the first opening and extending in the same directionthrough the connector sidewall. A suture can be arranged to run throughthe connector so that the enlarged tail end can be pulled in a directionaway from the proximal end of the retainer and then cinched against thesuture lock in the slot.

In a variation shown in FIGS. 21A-21B, a slot 630 may open in adirection transversely to a first opening 632 in the connector sidewallso that the tail may be pulled through the slot and away from theretainer in a first direction and the remaining suture segment canextend from the first opening in a generally opposite direction.

Other arrangements of connectors for suture retainers, particularly thearrangements of openings and/or slots to facilitate orientation of asuture retainer relative to the fascia, are contemplated as should beapparent to one of skill in the art. For example, and withoutlimitation, the sidecut, slot and/or opening may including varyingdirectional components to allow relative positioning of the sutureretainer and suture tail, so that the suture retainer may be rotated aswell as tipped over. Further, although each end of a suture has beendescribed as being associated with a respective suture retainer, theinvention is not so limited and only one end of a suture need beemployed with a suture retainer. In this latter embodiment, the otherend of the suture may be attached to a different component, such as aT-bar fastener, or may be free of any additional component.

An instrument for delivery of transfascial sutures 700, shown in FIGS.22-25C, is pre-loaded with a plurality of sutures. Each suture includesa first suture segment attached to a first suture retainer 750, a secondsuture segment attached to a second suture retainer 720, and anintermediate segment extending therebetween which may furtherincorporate a force distribution member.

The instrument includes a handle 702, an outer shaft 704, and a singledrive needle 706 located within the outer shaft about which the sutureretainer pairs are mounted in end-to-end fashion. Adjacent sutureretainers may be slightly spaced from each other, or in contact. Aproximal end of the drive needle may extend outside of the handle andmay be pushed forward to drive the tip of the needle to a deployedposition beyond the end of the shaft. The proximal end of the driveneedle may then be retracted to reposition the needle tip at a startingposition. Other arrangements for deploying and retracting the driveneedle are contemplated as should be apparent to one of skill in theart.

A biased loading member, such as a spring ending in a washer or otherstructure is adapted to act against a proximal end of the retainerstack, urging the retainer stack towards the distal tip. A resilientstop 708 extends inwardly from the shaft preventing further displacementof the stack in response to the biased loading member. Slightly morethan a retainer's length proximal of the distal tip, sufficient toaccount for projection of the piercing tip of the needle through theretainer, the drive needle includes an active drive and reload feature710. The drive and reload feature is biased into a drive profile toengage a distal-most retainer as the needle is deployed, imparting adrive force to the distal-most retainer that overcomes the resilientstop and forces the retainer through the puncture path in the abdominalwall patch and fascia that has been formed by the deploying needle.

As the needle retracts through the shaft on its return stroke, theactive drive and reload feature contacts the tip of the next sutureretainer, which has been advanced to the stop by the biased loadingmember. The rearward force on the active drive and reload feature as itcontacts the tip of the next suture retainer overcomes the bias for thedrive profile, causing the drive and reload feature to move into areloading profile that is adapted to pass through the retainer. Uponcompletion of the stroke, the drive and reload feature emerges proximalof the new distal-most retainer and biases again into the drive profile.

In one embodiment, the active drive and reload feature includes a cammember that is pivoted to the drive needle so that forces directedagainst the front of the cam member cause upward pivoting into a driveprofile, while forces directed to the back of the cam member causedownward pivoting into a reloading profile. As shown, and but oneexample of a drive and reload feature, is a wedge shaped memberpivotally mounted to the drive needle with an upright front face 712 anda downwardly inclining back face 714.

An instrument 800 for delivering transfascial sutures is shown in FIGS.26A-27 and includes a plurality of pre-loaded suture and suture forcedistribution members 802 a-f. The delivery instrument includes anelongated shaft 804 and a pair of needles 806 or other drive elementswhich may be configured similar to the needles and drive elementspreviously described so as to be controllably moved through theinstrument to pick up a pair of suture segments and transfasciallydeliver the suture and suture force distribution member. A distal end ofthe shaft includes a loading zone 810 and a pick-up position 812 for thesuture and suture force distribution members. The loading zone may bearranged at a first side of the shaft with the pick-up position onanother, preferably opposite, side of the shaft, with the needles orother delivery elements moveable through the pick-up position side ofthe shaft. The loading zone may include stacking walls, ribs or otherfeatures, projecting inwardly from the shaft, and that may be configuredto correspond with the contour of the suture force distribution membersto assist in aligning and guiding the position of the stack within theshaft.

The loading zone and pick-up position may overlap to some extent asshown in FIG. 27, such that a portion of the suture force distributionmember in the pick-up zone may eclipse a portion of the next distal-mostsuture force distribution member. A design factor for relative locationof the pick-up position and the stacking zone includes providing a clearpath for the needle pairs to travel through the pick-up position so asto grab the suture segments.

In the loading zone, the suture and suture force distribution membersmay be stacked, such as in a face-to-face orientation as shown and bebiased by a spring drive towards the distal tip of the instrument.Advance of the stack towards the distal tip is shown in FIG. 26D. Thedistal-most suture and suture force distribution member is moved,manually or automatically, to a pick-up position that is offset from therest of the stack as shown in FIG. 26D. For example, and withoutlimitation, a leaf spring, a cam element 814 formed or provided withinthe shaft and that cooperates with the spring drive, or other mechanicalarrangement may be located at the distal end of the loading zone to biasover the distal most suture force distribution member into the pick-upposition after the needle pair have been retracted proximal of thepick-up position. Other arrangements for translating, or otherwisemoving, the suture force distribution member and associated suturesegments to the pick-up position may be employed as should be apparentto one of skill in the art.

The pair of needles or other delivery elements are advanced to andthrough the pick-up position, picking up the suture segments anddragging the suture segments through the tissue as the needle isadvanced well beyond the end of the instrument. The suture forcedistribution member, similar to previous embodiments, may be fixed tothe suture segments or free-floating therealong. This deliveryinstrument is not limited to the shape or arrangement of the sutureforce distribution members shown nor to the position of the suturesegments relative to the suture force distribution members. Otherarrangements and configurations of sutures and suture force distributionmembers for use with a delivery instrument with attributes as justdescribed are contemplated as should be apparent to one of skill in theart.

In an alternative embodiment, a cartridge separate and apart from thedelivery instrument may similarly be loaded with one or more sutures andsuture force distribution members and configured to receive the tip ofthe separate delivery instrument to load a suture and suture forcedistribution member. The delivery instrument, now loaded with a sutureand suture force distribution member, may be removed from the cartridgeand inserted through a cannula or narrow incision into the abdominalcavity and applied to fire the suture transfascially. The depleteddelivery instrument may be withdrawn from the cavity and reloaded byagain inserting the tip of the delivery instrument into the cartridgeand picking-up the new distal-most suture and suture force distributionmember. As with the integrated delivery instrument and cartridgearrangement described previously, the separate cartridge may beconfigured to translate, or otherwise move, the suture forcedistribution member from the stacked loading position to the pick-upposition, with a leaf spring, cam, or other arrangement moving thesuture force distribution member to the pick-up position once the needlepairs have vacated the pick-up position.

A system 900 for actuating the needles or other drive elements of adelivery instrument is shown in FIGS. 28A-28B and includes a handle body902 which may be formed of a pair of handle sections as illustrated andwhich supports a rack and pinion drive system. A trigger 904 is mountedfor linear movement along a bar and is translatable against the force ofa spring 906 mounted about the bar towards the rear of the handle. Arack 908 governed by the trigger cooperates with a drive aspect 910 of apinion gear to rotate the pinion gear in response to movement of thetrigger. A separate rack 912, linked to a pair of needles 914 or otherdrive elements, moves in response to the rotation of the pinion gear,either towards the distal direction of the instrument so as to advancethe needles or other drive elements out of the device, or in theproximal direction to retract the needles or other drive elements backinto the shaft.

The handle body may include various mounts and support for the activecomponents including, without limitation, a support for the needle rack,stabilizer rods for the needles, a pinion/drive gear mount, and a limitfor distal movement of the trigger block. A pawl or other approach forproviding incremental movement of the trigger may be incorporated intothe handle arrangement. Incremental movements of the drive system may becoordinated to particular aspects of the suture delivery process. Forexample, and without limitation, the trigger stroke may havepredetermined stopping points, such as at suture pickup or at variousstages of needle deployment, allowing the physician to ensure it isappropriate to proceed to the next aspect of the stroke. Although anaxial translatable trigger is shown, other arrangements including apivoting trigger, and other actuators for a drive system, may beemployed as should be apparent to one of skill in the art. Further, therack and pinion drive system illustrated and described is but one ofmany drive systems that may be used to advance and retract the needlepairs or other drive elements of the delivery instrument.

An instrument for delivery of transfascial sutures 1000, shown in FIGS.29-32C, may be pre-loaded with a plurality of sutures. Each sutureincludes a first suture segment attached to a first suture retainer, asecond suture segment attached to a second suture retainer, and anintermediate segment extending therebetween which may furtherincorporate a force distribution member, if desired.

The instrument includes a hollow drive needle 1002 that may be locatedwithin an outer shaft (not shown) similar to those described above. Anactuation handle, also similar to those described above, may be providedat a proximal end of the shaft to actuate the instrument for deployingsutures.

Suture retainer pairs 1004 are supported within the needle in end-to-endfashion. Adjacent suture retainers may be slightly spaced from eachother, or in contact. The instrument may be configured to advance thestack of suture retainers along the length of the needle and deploy adistal-most suture retainer from the distal end of the needle inresponse to actuation of a control mechanism at the handle.

Each suture retainer 1004 may include one or more features thatcooperate with the needle 1002 to maintain the suture retainers in thestacked configuration within the needle while also permitting theretainers to be moved along the length of the needle for controlleddeployment. In one embodiment shown in FIGS. 29-31, each suture retainer1004 may include a pair of protrusions 1006, such as fingers, thatextend in an outward direction from opposing sides at a proximal end ofthe retainer and ride along elongated slots 1008 extending alongopposite sides of the needle. The fingers are configured to protrudeinto the slots and eventually engage with a distal end 1010 of each slotwhen a suture retainer is advanced to a distal-most stack positionwithin the needle. In this manner, as shown in FIG. 32, the distal-mostsuture retainer in the stack is restricted from advancing beyond thedistal-most stack position along the needle when its fingers 1006 engagethe distal ends 1010 of the slots 1008 to thereby retain the stack ofsuture retainers within the needle.

The suture retainers 1004 may be adapted to release from the needle uponapplication of a longitudinal force that is sufficient to overcome theengagement between the fingers 1006 of the distal-most retainer and thedistal end 1010 of the slot. In one embodiment, each finger may includea cam surface 1012 that connects with the end of the slot to deflect andcollapse the finger inwardly as the longitudinal force is applied todrive the suture retainer in the distal direction. As shown, the camsurface 1012 may be angled outwardly from the retainer in a proximaldirection. As shown in FIGS. 30-31, the distal portion of each retainermay be configured with a relief 1013, such as a slot, to receive thefingers of the adjacent retainer as the fingers become collapsed duringa deployment sequence. Such an arrangement may allow for a more compactdevice. However, it is to be appreciated that the retainer may employany suitable arrangement to facilitate stacking and release of theretainers as should be apparent to one of skill in the art.

When the fingers 1012 are fully collapsed into a low profile, as shownin FIG. 32A, the distal-most suture retainer may be advanced distallybeyond the distal-most stack position for deployment from the needle.The fingers may be resilient so that they return toward their originalexpanded position after deployment, making it more difficult for thesuture retainer to pass back through the puncture formed through thefascia and abdominal wall prosthesis. However, use of a resilient fingeris not a required feature and other engagement features may be employedas should be apparent to one of skill in the art. For example, andwithout limitation, the retainer may include shear pins or otherdeformable features that maintain the stack of suture retainers withinthe needle until deployment is desired.

A first pusher 1014 may be located within the shaft and be adapted toact against a proximal end of the retainer stack, urging the retainerstack towards the distal tip of the needle in response to actuation ofthe instrument. In one embodiment shown in FIGS. 30 and 32-32C, thefirst pusher 1014 may include a tube that is advanced along the lengthof the needle in response to actuation of the instrument. The firstpusher may include a distal end 1016 that is configured to engage with aproximal portion of the most proximal suture retainer. Advancement ofthe first pusher in the distal direction applies a longitudinal forcealong the stack of retainers to advance the distal-most suture retainerinto position for deployment from the needle. The first pusher 1014 maybe configured to index the stack of retainers a distance correspondingto the length of a suture retainer so that only the distal-most retaineris released upon each stroke of the pusher.

A second pusher 1018 may be located within the shaft and be adapted todrive the distal-most suture retainer from the needle in response toactuation of the instrument. In one embodiment, the second pusher 1018may include a drive wire that is adapted to extend and retract in areciprocating manner through the first pusher 1014 and the stack ofsuture retainers. As shown in FIG. 32A, the distal end 1020 of thesecond pusher is configured to engage with the collapsed proximal end ofthe distal-most suture retainer. Once engaged, distal extension of thesecond pusher 1018 drives the distal-most suture retainer from theneedle, as shown in FIG. 32B.

After deployment of the distal-most suture retainer, as shown in FIG.32C, the second pusher 1018 is retracted proximally to its initialposition for the next deployment sequence. The first pusher 1014 remainsin its indexed position and engaged with the most proximal retainer inthe stack to maintain the next distal-most suture retainer in positionat the distal end of the slot for the next deployment sequence.

Although the instrument 1000 has been described above using one needle,it is to be appreciated that the instrument may include first and secondneedles with each needle supporting a stack of retainers 1004 arrangedin end-to-end fashion. The instrument may be pre-loaded with a pluralityof sutures with each suture including a first suture segment attached toa suture retainer in the first needle and a second suture segmentattached to a correspondingly positioned suture retainer in the secondneedle. For example, and without limitation, the suture segments of asuture may be attached to the distal-most retainer in each needle. Ifdesired, a force distribution member may be provided with the suture ina manner described above.

For some transfascial suturing procedures, it may be desirable to employone or more suture retainers that may be deployed and/or implanted belowthe skin surface, for example, between the fascia and the dermal layer.An implantable suture retainer may be configured to anchor a suture orsuture segment using a knotless procedure.

An instrument 1100 for delivering a transfascial suture is shown inFIGS. 33-33B and may include a reusable unit and a disposable unitsimilar to those described above in connection with the instrument ofFIGS. 9-13. The reusable unit 1102 may include a handle (not shown), anelongated shaft 1104 and a drive assembly included within and actuatableat the handle. The disposable unit 1106 may include a tip 1108 andsuture assembly 1110. The reusable unit includes a pair of driveelements 1112, which may be in the form of needles, that extend alongthe elongated shaft and are deployable and retractable in response toactuation of a control mechanism at the handle.

As shown, the path 1114 of the drive elements or needles may diverge,increasing the spacing between the needles beyond the instrument and theamount of tissue purchase thereby. Alternatively, the drive elementpaths may be parallel or converging.

An implantable suture retainer 1120 may be located in each of the drivepaths, with each retainer connected to one of the suture segments 1122,1124 extending through the opening or openings in the tip body. Thesuture retainers are adapted to receive and be carried by the driveelements 1112 as they are advanced from the shaft of the reusable unit,through the tip body and along and beyond the distal extension of thetip. In one embodiment, the suture retainers each include an axialthrough-bore for receiving a portion of a needle tip. The bore and/orneedle may be configured so only part of the needle will project throughthe retainer. For example, and without limitation, the needle mayinclude a necked down narrow tip portion that is extendable through andbeyond the retainer bore, and a stepped up larger proximal portion thatis engageable with the retainer, for example with an internal orexternal shoulder of the retainer.

As shown, a force distribution member 1126 may be arranged in floatingrelationship with the suture segments. As shown in FIG. 33C, after bothsuture segments are fully deployed out of the instrument, the forcedistribution member and intermediate segment 1128 will position againstthe soft tissue repair patch.

The suture retainers 1120 are carried by the needles from the instrumentthrough the soft tissue repair prosthetic and/or fascia, presentingbelow the skin surface, for example, between the fascia and the skinlayer. Upon completion of the instrument stroke, the needles retractback through the fascia and through the abdominal wall patch, leaving afirst suture segment 1122 running from a first suture retainer locatedbetween the fascia and skin layer, to an intermediate segment 1128 andforce distribution member 1126 internal of the abdominal cavity andpositionable against the abdominal wall patch, and back to a secondsegment 1124 running from the force distribution member through theabdominal wall patch and fascia to a second retainer located between thefascia and skin layer.

The retainers may be configured so that they are unlikely to slip backthrough the needle puncture openings. In one embodiment, the proximalend portion 1130 of a retainer may expand from a collapsed configurationsuitable for delivery through the fascia to an expanded configurationafter deployment between the fascia and dermal layer. When expanded, theretainers anchor the suture segments in place without tying, or othersecuring, of the suture tails together. The retainers may be formed ofan absorbable material, such as PLA, having sufficient stiffness toanchor the suture and abdominal wall patch in position. However, theretainers may be formed of any suitable material, includingnon-absorbable material, as should be apparent to one of skill in theart.

The suture may be configured to draw the intermediate segment and/orforce distribution member toward the implanted retainers and against theabdominal wall patch. In one embodiment, the suture may be formed of astretchable material, such as polybutester, that becomes stretched andloaded during deployment of the retainers to thereby tension the suturesegments and automatically tighten the suture without having to manuallypull the suture or retainers to hoist and/or secure the patch inposition. For example, and without limitation, the suture segments maybe sized for a deployment of approximately 1.0-1.5 cm through thefascia. During deployment, the suture segments may be over-deployed toapproximately 2.0 cm to place sufficient tension on the suture segmentsfor anchoring the patch in position.

An instrument 1200 for delivering a transfascial suture is shown inFIGS. 34-34D and may include a drive element 1202, which may be in theform of a needle, and a suture assembly 1204 supported on the needle.The needle and suture assembly may be housed within an elongated shaft1206 and may be operated with a drive assembly included within andactuatable at a handle provided at a proximal end of the shaft.

The suture assembly 1204 may include a suture retainer 1208 connected toa first suture segment 1210 and a suture anchor 1212 connected to asecond suture segment 1214. As shown, the first suture segment may beslidably received through a locking member 1216, such as a locking knot,provided at the end of the second suture segment and adjacent the sutureanchor. A force distribution member 1218 may be arranged in floatingrelationship with the suture segments.

The suture retainer is adapted to receive and be carried by the needle1202, or other drive element, as it is advanced from the shaft of theinstrument. In one embodiment, the suture retainer includes an axialthrough-bore for receiving a portion of a needle tip. The bore and/orneedle may be configured in a manner similar to arrangements describeabove so only part of the needle will project through the retainer. Asshown, the suture assembly may extend along the exterior of the needle.However, it is to be appreciated that one or more features of the sutureassembly may be carried within the needle. For example, and withoutlimitation, the suture anchor may be received and carried in acorresponding cavity provided on the exterior surface of the needle toposition the suture anchor below the skin upon deployment of the sutureassembly.

As shown in FIG. 34A, the suture retainer 1208 is carried by the needlefrom the instrument through the soft tissue repair prosthetic P and/orfascia W, presenting on the other side of the abdominal wall and abovethe skin surface. Upon completion of the instrument stroke, as shown inFIG. 34B, the needle retracts back through the fascia and the abdominalwall patch, leaving the first suture segment 1210 running from thesuture retainer 1208 located exterior of the abdominal cavity, to theforce distribution member 1218 internal of the abdominal cavity andpositionable against the abdominal wall patch, and back to the secondsegment 1214 running from the force distribution member through theabdominal wall patch and fascia to the suture anchor 1212 which islocated below the skin. The first suture segment 1210 extends throughthe locking member 1216 adjacent the suture anchor 1212.

As shown in FIG. 34C, the suture assembly may be tightened to draw theforce distribution member against the wall patch by holding and pullingthe suture retainer to draw a length of the suture segment through thelocking member. If desired, a knot pusher 1220 may be slid along thefirst suture segment external to the abdominal cavity and pushed againstthe locking member to assist with tightening of the suture assembly. Asshown, the suture anchor may be adapted to toggle into an anchoringposition as the suture is tightened. When the suture assembly issufficiently tightened to secure the wall patch, excess length of thefirst suture segment may be cut below the skin and removed along withthe suture retainer.

A method of transfascial suturing, for example in the repair of anabdominal wall defect such as a ventral hernia, will now be described.The patient is prepared in the typical fashion for hernia surgery whichmay include administration of general anesthesia, identification of thehernia size and location, and shaving, washing and sterilization of thesurgical site. The abdominal cavity may be insufflated or otherwiseexpanded to separate the abdominal wall from organs located in theabdominal cavity. A trocar cannula may be inserted to provide cameraaccess to the cavity allowing the physician to visualize the surgicalsite. A separate laparoscopic cannula may be inserted into the abdominalwall cavity, or an incision (such as formed by a trocar) may be madeleading into the abdominal wall cavity, and an abdominal wall repairprosthetic then may be inserted, as described below, through suchcannula, incision, or other passageway into the abdominal cavity.

The prosthetic, which may be in the form of a patch, preferably isreduced in size to facilitate delivery through the slender cannula orincision. For example, and without limitation, the prosthetic may berolled, folded, or otherwise collapsed into a shape suitable for passagethrough the narrow approach to the abdominal cavity. Once located withinthe cavity, the prosthetic is unfurled or otherwise enlarged, manuallyor inherently under its own power, and then is positioned relative tothe defect, preferably with a margin of at least several centimetersprojecting beyond the edges of the defect. Delivery and enlargement ofthe patch may be facilitated by a mesh introducer such as aPRECISIONPASS instrument available from Davol Inc., assignee of theinstant application. Alternatively, a patch deployment assist device,such as an inflatable deployment assist balloon as illustrated in FIG.35, may be employed to deliver, expand, and/or position the prostheticagainst the abdominal wall relative to the defect.

In a representative method, the patch is reduced along with a deflateddeployment assist device, to a slender size such as by rolling the patchand deployment assist device into a cylindrical shape. One or moreattachment components on the deployment assist device may help mount thepatch to the deployment assist device. An inflation tube for thedeployment assist device may be routed through the patch and thengrasped, once the deployment assist device and patch are in theabdominal cavity, by a suture passer or other instrument that has beeninserted into the abdominal cavity from outside of the patient. Thesuture passer is withdrawn, externalizing the inflation tube. The end ofthe inflation tube outside of the patient may be fluidly connected to aninflation source. Introduction of an inflation medium through theinflation tube will expand the balloon, unfurling the patch into asubstantially planar configuration or such other end-use configurationas may be desired. The patch is positioned relative to the defect andwhen appropriately located, the inflation tube may be pulled fromoutside of the patient to hoist the deployment assist device and,consequently, the patch carried thereby against the abdominal wall. Ahemostat, clamp or other instrument, may be applied to the inflationtube to retain the deployment assist device in position. If desired, thepatch still may be rotated to optimize angular orientation of the patch.

The prosthetic patch may be maintained in position against the abdominalwall by the deployment assist device or, alternatively, by use oflaparoscopic instruments such as graspers. At this time, in thediscretion of the physician, a plurality of coils, tacks, staples, orother mechanical fixation elements may be applied through the patch intothe abdominal wall.

A single or twin-needle, or other single or twin-drive element, suturedelivery instrument is then inserted through the cannula or narrowincision into the abdominal cavity. The instrument includes one or moresuture and suture force distribution member assemblies, such as any ofthe arrangements previously described. From within the abdominal cavityand under camera visualization, the tip of the suture deliveryinstrument is placed against a margin of the patch, or other location asdesired by the physician. At least one trigger or other control isactuated, from outside of the patient, driving one needle or a pair ofneedles simultaneously or in a sequence, through the distal end of theinstrument where the needles associate, if they were not pre-associated,with respective suture segments. The needle or needles advance out ofthe instrument and pierce through the patch margin, the abdominal wall(fascia) and, if desired, also through subcutaneous tissue, fat andskin, with the needles paying out the suture segments as they travelthrough the patch and anatomy.

The tail ends or sections of the suture segments may be retained on theexterior side of the abdominal cavity by application of hemostats,clamps, or other devices, or by grasping by medical staff, to preventthe suture segments from slipping back into the abdominal cavity, aswell as to maintain tension on the sutures thereby keeping the patchpositioned against the internal abdominal wall. The tail ends orsections external of the abdominal cavity may be pulled to hoist thepatch against the abdominal wall and then the hemostats or otherinstruments applied, or reapplied, to manage the suture ends and patchlocation. In certain embodiments, suture retainers, such as thosepreviously described, may be employed to manage the suture tails postdeployment.

As the suture is delivered through the fascia, and/or in response to thepulling, external of the abdominal cavity, of the suture tails orsegments that have been delivered through the fascia, a suture forcedistribution member becomes lodged against the prosthetic inside of theabdominal wall cavity. Advantageously, the puncture openings through thepatch formed by the needles are covered, at least in part, by the forcedistribution member. By covering the puncture openings, the suture forcedistribution member helps prevent adhesions between the viscera and thetissue infiltratable side of the patch. The delivery of sutures may berepeated, for example at spaced locations about the periphery of thepatch, and either after deployment of each suture or after all of thesutures have been delivered, respective suture tail pairs may beknotted, excess suture length trimmed, and the skin over the suture knotclosed by stitching, adhesive strip or otherwise. The deployment assistdevice may be separated from the patch and removed at any time afterproper positioning of the patch, and preferably after the patch has atleast been provisionally secured such as by initial suturing ormechanical fixation, and may remain in the abdominal cavity untiltransfascial suturing has been completed. As mentioned, mechanicalfixation elements may, at the discretion of the physician, be applied tothe patch prior to transfascial suturing. Alternatively, such mechanicalfixation may occur after transfascial suturing, or the transfascialsuturing procedure may be concluded without deploying any mechanicalfixation elements.

The soft tissue repair prosthetic may be formed of a porous material,such as a knit, woven or non-woven fabric, or may be composed of asolid, substantially non-porous, or micro-porous material. Theprosthesis may be formed of one or more layers of the same or dissimilarmaterial, and the layers may be stacked one on top of the other,side-to-side, or include a combination of both stacking arrangements.The prosthesis may be formed with portions that are tissue infiltratableand other portions that are less tissue infiltratable or are non-tissueinfiltratable, providing selected areas of the repair device withdifferent tissue ingrowth and adhesion resistant properties. Theprosthesis may be formed of permanent material, resorbable material, ora combination of permanent and resorbable materials. It should beappreciated that the prosthesis may be formed of any biologicallycompatible material, synthetic or natural, suitable for repairing atissue or muscle wall defect as would be apparent to one of skill in theart. Depending upon the surgical application, the prosthesis may be inthe form of a patch, plug or combination patch and plug.

In a representative embodiment, the soft tissue repair prosthetic is inthe form of a ventral hernia repair patch, and may include a tissueinfiltratable layer and a barrier layer. The tissue infiltratable layermay include one or more sheets of surgical mesh fabric, such as apolypropylene knit. The barrier layer may be a sheet of synthetic ornatural barrier material; for example, and without limitation, a sheetof ePTFE may be stitched, heat fused or otherwise connected to apolypropylene sheet. In the described method of ventral hernia repair,the polypropylene side would face the abdominal wall and the ePTFE sidewould face the viscera.

Surgical materials which are suitable for tissue or muscle reinforcementand defect correction may be utilized include, but are not limited to,BARD MESH (available from C.R. Bard, Inc.), SOFT TISSUE PATCH(microporous ePTFE—available from W.L. Gore & Associates, Inc.);SURGIPRO (available from US Surgical, Inc.); TRELEX (available fromMeadox Medical); PROLENE and MERSILENE (available from Ethicon, Inc.);and other mesh materials (e.g., available from Atrium MedicalCorporation). Biologic materials, including XENMATRIX, COLLAMEND, andALLOMAX (all available from C.R. Bard, Inc.) or COOK SURGISIS (availablefrom Cook Biomedical, Inc.) may also be used. Resorbable materials,including polyglactin (VICRYL—available from Ethicon, Inc.) andpolyglycolic acid (DEXON—available from US Surgical, Inc.). Thesematerials may be used alone in a soft tissue repair prosthetic, incombination with one another, or in combination with other materials.The fabric may be formed from multifilament yarns and any suitablemethod, such as knitting, weaving, braiding, molding and the like, maybe employed to form the mesh material. It should be appreciated thatwhen the soft tissue repair prosthesis is in the form of a patch, it maybe configured in many shapes, including, but not limited tosubstantially flat, concave, convex, and concave-convex, and may, forexample, be in the shape of a square, rectangle, circle, or ellipse.Further, the patch may be loaded with one or more drugs including,without limitation, an analgesic or antibiotic.

The suture may be formed of a synthetic or natural material, and may beabsorbable or non-absorbable. For some applications, the suture may beformed of a stretchable material. Representative suture materialsinclude, but are not limited to, polypropylene, PTFE, nylon, polyester,polybutester, silk, PGA, PLA/PGA, caprolactone, catgut,polyhydroxyalkanoate and PDO.

The above and other aspects of the invention will be appreciated fromthe detailed description and claims. It should be understood thatalthough aspects of the invention have been described with reference toillustrative embodiments, aspects of the invention are not limited tothe embodiments described. Also, aspects of the invention may be usedalone, or in any suitable combination with other aspects of theinvention.

1. A method of inserting an instrument into an abdominal cavity, theinstrument including at least one tissue piercing member having a sharpend adapted to pierce abdominal wall tissue, the instrument having anon-piercing mode with the sharp end of the tissue piercing member beingshielded against contact with abdominal wall tissue and a piercing modewith the sharp end of the tissue piercing member being available forcontact with abdominal wall tissue, the method comprising acts of: (a)inserting the instrument in the non-piercing mode into the abdominalcavity with the sharp end of the at least one tissue piercing memberbeing shielded from contact with the abdominal wall tissue; (b)positioning the instrument in the non-piercing mode adjacent theabdominal wall; (c) after act (b), actuating the instrument to thepiercing mode; and (d) advancing the at least one tissue piercing memberthrough at least a part of the abdominal wall with the instrument in thepiercing mode.
 2. The method of claim 1, wherein act (a) includesinserting the instrument into the abdominal cavity with the sharp end ofthe at least one tissue piercing member retracted away from a distal endof the instrument in the non-piercing mode, and act (b) includesextending the sharp end of the at least one tissue piercing memberbeyond the distal end of the instrument in the piercing mode.
 3. Themethod of claim 2, wherein the instrument includes an elongated shaftextending from a handle, and wherein act (a) includes inserting theinstrument into the abdominal cavity with the sharp end of the at leastone tissue piercing member retracted away from a distal end of theelongated shaft, and act (d) includes extending the sharp end of the atleast one tissue piercing member beyond the distal end of the shaft. 4.The method of claim 2, wherein act (b) includes placing the distal endof the instrument against a soft tissue repair prosthetic and/or theabdominal wall before advancing the tissue piercing member through apart of the abdominal wall.
 5. The method of claim 1, wherein act (d)includes advancing the at least one tissue piercing member through asoft tissue repair prosthetic before advancing the tissue piercingmember through a part of the abdominal wall.
 6. The method of claim 5,further comprising repeating acts (b) to (d) in one or more locationsabout a peripheral segment of the soft tissue repair prosthetic.
 7. Themethod of claim 1, wherein the instrument is an instrument fordelivering a transfascial suture, the instrument having at least oneneedle and being loaded with at least one suture, and wherein act (d)includes advancing the at least one needle through at least a part ofthe abdominal wall.
 8. The method of claim 7, wherein the instrument hasa pair of needles and is loaded with the at least one suture defined bya pair of suture segments, each needle associated with one of the pairof suture segments, and act (d) includes advancing each of the needlesfrom the suturing instrument through at least part of the abdominalwall.
 9. The method of claim 8, wherein the suture includes anintermediate segment between the pair of suture segments, and whereinact (d) includes not passing the intermediate segment through any partof the abdominal wall.
 10. The method of claim 8, wherein act (d)includes simultaneously passing the pair of needles through a softtissue repair prosthetic and at least part of the abdominal wall. 11.The method of claim 8, further comprising, after act (d), securing thepair of suture segments together.
 12. The method of claim 8, wherein thesuture includes a suture force distributing member and act (d) includespositioning the suture force distributing member against a soft tissuerepair prosthetic.
 13. The method of claim 8, wherein act (d) includesadvancing the pair of needles in substantially parallel paths throughthe at least part of the abdominal wall.
 14. The method of claim 8,wherein act (d) includes advancing the pair of needles in divergingpaths through the at least part of the abdominal wall.
 15. The method ofclaim 8, wherein act (d) includes passing the pair of suture segmentsthrough fascia and muscle and further through skin.
 16. The method ofclaim 8, wherein a length of each suture segment is contained within anassociated needle.
 17. The method of claim 8, wherein the pair of suturesegments each include a tail section and a proximal section, and act (d)includes passing the tail section, before the proximal section, throughthe at least part of the abdominal wall.
 18. The method of claim 8,wherein the pair of suture segments each include a tail section and aproximal section, and act (d) includes passing the proximal sectionbefore the tail section through the soft tissue repair prosthetic.